FDA records indicate that there are no current recalls for this drug.
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Pain Relief Pm Extra Strength Recall
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Questions & Answers
Side Effects & Adverse Reactions
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
if a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- drowsiness will occur
- avoid alcoholic drinks
- do not drive a motor vehicle or operate machinery
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
ask a health professional before use.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away: Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- with any other product containing diphenhydramine, even one used on skin
- in children under 12 years of age
- liver disease
- a breathing problem such as emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
- glaucoma
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
- sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Pain Relief Pm Extra Strength Manufacturers
- Quality Choice (Chain Drug Marketing Association)
- Top Care (Topco Associates Llc)
- Allegiant Health
Pain Relief Pm Extra Strength | Allegiant Health
Adults and children 12 years of age and older:Take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
Children under 12 years of age:Do not use this adult strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems
- Assured / Dollar Tree (Greenbrier International, Inc.)
Pain Relief Pm Extra Strength | Assured / Dollar Tree (greenbrier International, Inc.)
do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. children under 12 years: do not use - Chain Drug Marketing Association
Pain Relief Pm Extra Strength | Chain Drug Marketing Association
do not take more than directed (see overdose warning) adults and children 12 years and over take 2 gelcaps at bedtime do not take more than 2 gelcaps of this product in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage - Chain Drug Marketing Association
Pain Relief Pm Extra Strength | Chain Drug Marketing Association
do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets at bedtime do not take more than 2 caplets of this product in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage - Hannaford Brothers Company
Pain Relief Pm Extra Strength | Hannaford Brothers Company
do not take more than directed (see Liver warning).Adults and children 12 years and over:
take 2 caplets at bedtime do not take more than 2 caplets of this product in 24 hoursChildren under 12 years: do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Safeway
Pain Relief Pm Extra Strength | Safeway
• do not take more than directed (see Liver warning)adults and children 12 years and over
• take 2 caplets at bedtime • do not take more than 2 caplets of this product in 24 hourschildren under 12 years
do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Kroger Company
Pain Relief Pm Extra Strength | Kroger Company
• do not take more than directed (see Liver warning)adults and children 12 years and over
• take 2 caplets at bedtime • do not take more than 2 caplets of this product in 24 hourschildren under 12 years
do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Publix Super Markets Inc
Pain Relief Pm Extra Strength | Publix Super Markets Inc
• do not take more than directed (see Liver warning)adults and children 12 years and over
• take 2 caplets at bedtime • do not take more than 2 caplets of this product in 24 hourschildren under 12 years
do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Topco Associates Llc (Top Care)
- Topco Associates Llc (Top Care)
Pain Relief Pm Extra Strength | Topco Associates Llc (top Care)
Directions do not take more than directed (see overdose warning)adults and children 12 years and over
take 2 caplets at bedtime do not take more than 2 caplets of this product in 24 hourschildren under 12 years
do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Geiss, Destin & Dunn, Inc (Goodsense)
- Cvs Pharmacy
- Kroger Company
Pain Relief Pm Extra Strength | Kroger Company
• do not take more than directed (see Liver warning)adults and children 12 years and over
• take 2 gelcaps at bedtime • do not take more than 2 gelcaps of this product in 24 hourschildren under 12 years
do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Hyvee Inc
- Hyvee Inc
- Kroger Company
Pain Relief Pm Extra Strength | Kroger Company
• do not take more than directed (see Liver warning)adults and children 12 years and over
• take 2 geltabs at bedtime • do not take more than 2 geltabs of this product in 24 hourschildren under 12 years
do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Supervalu (Equaline)
- Geiss, Destin & Dunn, Inc (Goodsense)
- Equaline (Supervalu)
- Cvs Pharmacy
- Amerisourcebergen (Good Neighbor Pharmacy)
- Top Care (Topco Associates Llc)
- Publix Super Markets Inc
- Top Care (Topco Associates Llc)
Pain Relief Pm Extra Strength | Precision Nuclear Llc
2.1 Rest Imaging Study Aseptically withdraw Ammonia N 13 Injection from its container and administer 10-20 mCi (0.368 �0.736 GBq) as a bolus through a catheter inserted into a large peripheral vein. Start imaging 3 minutes after the injection and acquire images for a total of 10 - 20 minutes. 2.2 Stress Imaging Study If a rest imaging study is performed, begin the stress imaging study 40 minutes or more after the first Ammonia N 13 injection to allow sufficient isotope decay. Administer a pharmacologic stress-inducing drug in accordance with its labeling. Aseptically withdraw Ammonia N 13 Injection from its container and administer 10-20 mCi (0.368 - 0.736 GBq) of Ammonia N 13 Injection as a bolus at 8 minutes after the administration of the pharmacologic stress-inducing drug. Start imaging 3 minutes after the Ammonia N 13 Injection and acquire images for a total of 10-20 minutes, 2.3 Patient PreparationTo increase renal clearance of radioactivity and to minimize radiation dose to the bladder, ensure that the patient is well hydrated before the procedure and encourage voiding as soon as a study is completed and as often as possible thereafter for at least one hour.
2.4 Radiation DosimetryThe converted radiation absorbed doses in rem/mCi are shown in Table I. These estimates are calculated from the Task Group of Committee 2 of the International Commission on Radiation Protection.1
Table 1: N 13 Absorbed Radiation Dose Per Unit Activity (rem/mCi) for Adults and Pediatric Groups. Organ Age (years) Adult 15 10 5 1 * Upper large intestine † Lower large intestine Adrenals 0.0085 0.0096 0.016 0.025 0.048 Bladder wall 0.030 0.037 0.056 0.089 0.17 Bone surfaces 0.0059 0.0070 0.011 0.019 0.037 Brain 0.016 0.016 0.017 0.019 0.027 Breast 0.0067 0.0067 0.010 0.017 0.033 Stomach wall 0.0063 0.0078 0.012 0.019 0.037 Small intestine 0.0067 0.0081 0.013 0.021 0.041 *ULI 0.0067 0.0078 0.013 0.021 0.037 †LLI 0.0070 0.0078 0.013 0.020 0.037 Heart 0.0078 0.0096 0.015 0.023 0.041 Kidneys 0.017 0.021 0.031 0.048 0.089 Liver 0.015 0.018 0.029 0.044 0.085 Lungs 0.0093 0.011 0.018 0.029 0.056 Ovaries 0.0063 0.0085 0.014 0.021 0.041 Pancreas 0.0070 0.0085 0.014 0.021 0.041 Red marrow 0.0063 0.0078 0.012 0.020 0.037 Spleen 0.0093 0.011 0.019 0.030 0.056 Testes 0.0067 0.0070 0.011 0.018 0.035 Thyroid 0.0063 0.0081 0.013 0.021 0.041 Uterus 0.0070 0.0089 0.014 0.023 0.041 Other tissues 0.0059 0.0070 0.011 0.018 0.035 2.5 Drug Handling Inspect Ammonia N 13 Injection visually for particulate matter and discoloration before administration, whenever solution and container permit. Do not administer Ammonia N 13 Injection containing particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations. Wear waterproof gloves and effective shielding when handling Ammonia N 13 Injection. Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Ammonia N 13 Injection. The contents of each vial are sterile and non-pyrogenic. Use appropriate safety measures, including shielding, consistent with proper patient management to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Before administration of Ammonia N 13 Injection, assay the dose in a properly calibrated dose calibrator. - Walgreens
- Equaline (Supervalu)
- Assured / Dollar Tree (Greenbrier International, Inc.)
Pain Relief Pm Extra Strength | Assured / Dollar Tree (greenbrier International, Inc.)
do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. children under 12 years: do not use - Meijer Distribution Inc
Pain Relief Pm Extra Strength | Meijer Distribution Inc
• do not take more than directed (see Liver warning)adults and children 12 years and over
• take 2 geltabs at bedtime • do not take more than 2 geltabs of this product in 24 hourschildren under 12 years
do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Equate (Walmart Stores, Inc.)
- Supervalu Inc.
- P And L Development Of New York Corporation (Readyincase)
Pain Relief Pm Extra Strength | P And L Development Of New York Corporation (readyincase)
do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. children under 12 years: do not use - Good Sense (Geiss, Destin & Dunn, Inc.)
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